info@augurex.com
Transforming Patient Management

Quality/Regulatory Manager

LOCATION: Vancouver, BC, Canada    CLOSES: May 10, 2018

SUMMARY

The Quality/Regulatory Manager will play a key role in implementing and maintaining Augurex’s ISO 13485-compliant Quality System and supporting regulatory activities for current and pipeline Augurex products.  This position reports to the Senior Director, Biomarker Development.

ROLE AND RESPONSIBILITIES

  • Lead the implementation, maintenance and continuous improvement of an efficient, ISO 13485:2016-compliant Quality Management System
  • Assist the Research and Development team with risk management activities and provide guidance on quality assurance/quality control requirements
  • Assist with the preparation of regulatory submissions for the US FDA, EU, Health Canada and other international Competent Authorities
  • Maintain all national registrations, licenses, listing, and other certifications as required
  • Carry out global safety reporting and complaint handling requirements in accordance with regulations
  • Ensure product labelling and promotional materials are compliant with regulations
  • Other related duties as assigned

QUALIFICATIONS AND EXPERIENCE

  • Minimum educational requirement of B.Sc Degree in biological sciences, or equivalent combination of education and experience
  • Minimum of three years of experience managing quality systems in the medical device or pharmaceutical industry; experience in medical device/IVD compliance and regulatory preferred
  • In-depth knowledge of Canadian, US and European regulations, ISO 13485 and ISO 14971
  • Track record of strategic leadership, built on a foundation of excellent prioritization
  • Strong organizational and project management skills with the ability to deliver results on schedule in a fast-paced, dynamic environment
  • Superior analytical, problem solving and technical writing skills
  • Ability to thrive in a rapidly evolving organization and embrace a culture of growth and change
  • A can-do, winning attitude and a strong supportive team player
  • Excellent interpersonal skills and oral and written communication skills
  • Excellent computer skills (MS Office Suite) including MS Project

HOW TO APPLY

We are an equal opportunity employer and invite applications from all qualified individuals. To apply for this opportunity, please send your resume and cover letter to hr@augurex.com with “QA/RA Manager Application” in the subject line. While we thank all interested applicants only those candidates who are short listed will be contacted.

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